Identity
- Trade Name
- Duo Ti Expandable Interbody Fusion System FDA UDI
- Generic Name
- Metallic spinal interbody fusion cage FDA UDI
- Device Name
- Duo Ti Angled Trial, 14mm, 15° FDA UDI
- Model / Reference
- 86-11-23-14 FDA UDI
- Description
- Duo Ti Angled Trial, 14mm, 15° FDA UDI
Identifiers
- Catalog Number
- 861-0047 FDA UDI
- Primary DI / UDI-DI
- M7408610047 FDA UDI
- 510(k) Number
- K210155 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Metallic spinal interbody fusion cage FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Polymeric spinal interbody fusion cageMetallic spinal interbody fusion cage
Duo Ti Expandable Interbody Fusion System by Spineology Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Metallic spinal interbody fusion cage.
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Cleared under the same submission
K210155 also covers:
- Duo Ti Expandable Interbody Fusion System — SPINEOLOGY INC.
- Duo Ti Expandable Interbody Fusion System — SPINEOLOGY INC.
- Duo Ti Expandable Interbody Fusion System — SPINEOLOGY INC.
- Duo Ti Expandable Interbody Fusion System — SPINEOLOGY INC.
- Duo Ti Expandable Interbody Fusion System — SPINEOLOGY INC.
- Duo Ti Expandable Interbody Fusion System — SPINEOLOGY INC.
- Duo Ti Expandable Interbody Fusion System — SPINEOLOGY INC.
- Duo Ti Expandable Interbody Fusion System — SPINEOLOGY INC.
- Duo Ti Expandable Interbody Fusion System — SPINEOLOGY INC.
- Duo Ti Expandable Interbody Fusion System — SPINEOLOGY INC.
- Duo Ti Expandable Interbody Fusion System — SPINEOLOGY INC.
- Duo Ti Expandable Interbody Fusion System — SPINEOLOGY INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Spineology Inc.
Sources (1)
- FDA UDI d6eca08c-a7d9-4c87-9ba7-63bee94bcd26 36 fields · synced May 31, 2026